Plantar fasciitis is one of the most common causes of heel pain, which accounts for approximately 15% of all foot-related complaints. This condition occurs in a wide variety of individuals. Commonly, age at onset is in the mid-40's, but plantar fasciitis can develop at any age. Many studies have shown a female-male predominance of 3:1. 65% of patients exhibiting plantar fasciitis are overweight. Approximately 22% of all patients with plantar fasciitis have moderate pronation; about 15% have high-arched, ridge foot; and the remainder have an anatomically normal or non-affected foot. Only 45% of the patients who undergo radiography for suspected plantar fasciitis are found to have a subcalcaneal or "bone" spur.
Evidence of the need for effective therapy is apparent when it is considered that over 95% of all heel pain is diagnosed as plantar fasciitis. Plantar fasciitis is best described as an inflammation of the ligament that runs from the heel to the ball of the foot, which helps support the arch. Patients with plantar fasciitis will experience pain, upon standing, on the bottom or inside of their heel. Typically, the pain is worse in the morning when getting out of bed and after resting when standing up.
Typically the primary anatomic cause of plantar fasciitis is some degree of microtrauma and tearing at the site of the Plantar Fascia insertion. These abnormalities, which may also be present at the origin of the Plantar Fascia, result from repetitive trauma and collagen degeneration and angiofibroblastic hyperplasia. Upon physical examination the range of motion of the affected ankle is less than that of the contralateral ankle. By pressing the thumb against the middle of the affected heel, the physician can delineate the area of the Plantar Fascial pain. Pressure similarly applied underneath the calcaneus reveals the area of subcalcaneal pain. The correlation between plantar fasciitis and subcalcaneal spurs is not significant, therefore radiographic findings are not specific. Conservative treatment, including night splints, results in relief of plantar fasciitis in 85% of patients. In 15% of patients in whom this approach fails, surgery is indicated.
One medical method known in the art in reducing Plantar Fascial pain is to stretch the Plantar Fascia for a period of time. By keeping the Plantar Fascia on stretch, it is believed that an ultimate reduction of the internal tension of the Plantar Fascia can be achieved. Through this treatment, it is believed that the pain associated with this medical condition can be reduced, and possibly eliminated.
A typical treatment program would have the patient wear the splint while sleeping, and remove the splint immediately upon awakening in the morning. The patient will continue wearing the night splint for a 3-month period. After that time the patient will be weaned off of the splint in 2-week increments, using the device every other night, then every third night, then every fourth night, and from then on as needed.
A number of plantar fasciitis night splints are known in the art. However, none have the suspension architecture or offer the comfort, ease of use, compactability, or degrees of rotation and angulation of the present device.
By way of illustration of the state of the art, U.S. Pat. No. 4,649,939, issued to R. Curtis on Mar. 17, 1987 utilized over a shoe. U.S. Pat. No. 5,038,762, issued to H. Hess, et. al., on Aug. 13, 1991, teaches of a U-Shaped yoke which can be wrapped about the heel and ankle. U.S. Pat. No. 5,090,404, issued to C. Kallassy on Feb. 25, 1992, teach of another way to place a strap about the heel and foot. U.S. Pat. No. 5,257,969 issued to C. Mance on Nov. 2, 1993 teaches of a foot support which consists of a toe pouch and straps the wrap about the ankle. U.S. Pat. No. 5,425,701 issued to C. Oster et al. on Jun. 20, 1995, teaches of a boot with upright struts which attach to a foot pad designable for each patient's foot shape. U.S. Pat. No. 5,472,411 issued to H. Montag, et. al., on Dec. 5, 1995 teaches of a U-shaped flexible joint collar which wraps about the foot, heel and ankle. U.S. Pat. No. 5,620,413, issued to D. Olson on Jul. 14, 1995 teaches of an ankle brace and wrap comprised of a support sleeve to fit over the foot. U.S. Design Pat. No. Des. 388,174 issued to W. Stano on Dec. 23, 1997 teaches of a ankle brace which wraps about the lower leg, ankle, and foot. U.S. Pat. No. 5,645,525, issued to R. Krivosha on Jul. 8, 1997 teaches of a heel stabilizing device which fits over the foot and heel. While these devices teach of flexible means of foot support, they do not teach a means to keep the foot on stretch which would properly facilitate the treatment indicated for a diagnosis of plantar fasciitis.
U.S. Pat. No. 4,320,748, issued to W. Racette, et al., on Nov. 20, 1980 teaches of a semi-rigid shell which wraps about the leg from the knee below and consists further of a heal plate pivotally connected to said shell. U.S. Pat. No. 4,693,239 issued to W. Clover on Sep. 15, 1987, teaches of a semi-rigid shell similar to the Racette et al. patent, but allows for use in the presence of soft tissue damage. U.S. Pat. No. 5,209,722 issued to J. Mikalus, et al., on May 11, 1993 teaches of an ankle brace consisting of a semi-rigid plates about the leg and a pivotally connected semi rigid foot plate. While these patents teach us of durable means of providing support to the leg, ankle and foot, they do not teach suspension architecture to keep the foot on stretch which would properly facilitate the treatment indicated for a diagnosis of plantar fasciitis.
U.S. Pat. No. 5,603,692, issued to R. Maxwell on Feb. 18, 1997, teaches of a rigid leg support which would keep the foot on stretch at a 90.degree. angle. U.S. Pat. No 5,605,535, issue to J. Lepage on Feb. 25, 1997 teaches of a load bearing foot brace with a pair of splint arms which, in conjunction, will keep the ankle on stretch at a 90.degree. angle. These patents teach of a means to keep the ankle on stretch, however they are limited in the angulation at 90.degree., lack tension adjustment features, and prove to be uncomfortable to the patient wearing such devices.
U.S. Pat. No. 5,718,673 issued to C. Shipstead on Feb. 17, 1998 teaches of an ankle wrap that is connected to a foot wrap by means which allow for keeping the ankle on stretch at a 90.degree. angle. This teaches a less uncomfortable means to keep the ankle on stretch, but does not provide the degrees of angulation, nor means for applying an ice/cold pack this current invention teaches.
In summary, while night splints have been used in the past for plantar fasciitis, all are deficient in either comfort, suspension architecture, adjustability, or ease of patient use.